Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-06 @ 3:46 PM
Study NCT ID:
NCT03045393
Status:
WITHDRAWN
Last Update Posted:
2018-07-05
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRĪ±)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMGN853
Brief Summary:
The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.
Detailed Description:
The folate receptor alpha protein is important in tumor growth and can be over-expressed in some tumor cells. The word "over-expressed" in this situation means that there are too many copies of the protein on the surface of the cell when compared to a healthy, normal cell, and this helps the tumor continue to grow in size. Mirvetuximab soravtansine acts by targeting the folate receptor in tumor cells. In animal models, mirvetuximab soravtansine is highly effective in decreasing tumor size. This suggests that mirvetuximab soravtansine may help shrink or stop growth of folate receptor alpha positive breast cancer in this study.
In this study the investigator will be looking at how folate receptor alpha expression changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will also look to evaluate the safety of this regimen, measure any change in tumor size, associate folate receptor alpha expression with a change in tumor size, and describe any changes in Ki-67 and percent of apoptotic cells in this population.
In this study the investigator will be looking at how folate receptor alpha expression changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will also look to evaluate the safety of this regimen, measure any change in tumor size, associate folate receptor alpha expression with a change in tumor size, and describe any changes in Ki-67 and percent of apoptotic cells in this population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: